Abstract
Introduction Eptacog alfa (activated) is a recombinant activated factor VII (rFVIIa) used for the treatment and prevention of bleeding episodes in patients with congenital hemophilia with inhibitors. Frequent dosing requirements make the use of an automated bolus infusion pump a promising alternative to manual administration. Aims The objective of this in vitro study was to evaluate the physical and chemical stability of room temperature–stable rFVIIa at 25°C over 24 hours in an automated bolus infusion pump. Methods An automated bolus infusion pump with preset bolus injection intervals of 2 to 6 hours was used. Samples of rFVIIa were analyzed for critical quality parameters, presence of leachables, and microbiological growth. The infusion system was evaluated visually. Results rFVIIa is physically and chemically stable when used in an automated bolus infusion pump system for up to 24 hours at 25°C. All critical quality parameter results were within the shelf-life limits and complied with the acceptance criteria. Leachables were observed at concentrations within their respective acceptance criteria. No visual changes in the syringe or infusion tube were observed; inherent particles in the reconstituted rFVIIa similar in size and description to those previously found in rFVIIa were seen. No microbiological growth was detected. Conclusions rFVIIa is stable in a bolus infusion pump system for up to 24 hours at 25°C. Bolus injection intervals of 2 to 6 hours can be used without physical or chemical changes to rFVIIa. This study supports the use of an automated bolus infusion pump in the hospital setting, across all indications for rFVIIa.
Highlights
Eptacog alfa is a recombinant activated factor VII used for the treatment and prevention of bleeding episodes in patients with congenital hemophilia with inhibitors
This study supports the use of an automated bolus infusion pump in the hospital setting, across all indications for rFVIIa
Specific activity of rFVIIa samples taken at time points 6, 12, and 24 hours were between 49 and 59 international units (IU)/μg
Summary
Eptacog alfa (activated) is a recombinant activated factor VII (rFVIIa) used for the treatment and prevention of bleeding episodes in patients with congenital hemophilia with inhibitors. Frequent dosing requirements make the use of an automated bolus infusion pump a promising alternative to manual administration. Eptacog alfa (activated) (NovoSeven, Novo Nordisk A/S) is a recombinant activated factor VII (rFVIIa) used for the treatment and prevention of bleeding episodes in patients with congenital hemophilia with inhibitors.[1,2]. The dosing schedule of rFVIIa for congenital hemophilia with inhibitors as per the product label is intravenous bolus injection at 90 μg/kg body weight every 2 to 3 hours.[1,2] The dosing frequency of rFVIIa can make it difficult to maintain the required schedule of reconstitution and administration, due to the time and resources required. For surgical patients in the perioperative period, failure to administer rFVIIa at the designated time intervals may increase the risk of breakthrough bleeding and result in poor patient outcomes.[4] received November 21, 2018 accepted after revision January 4, 2019
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